Last Updated on July 17, 2021 by The Health Master
The Drug Controller General (India) has classified 112 medical devices related to anesthesiology, which is used in taking care of a patient before, during and after surgery, under Medical Devices Rules vide DCGI notice dated 12-07-2021.
The devices including pulse oximeter, anesthesia machine, tracheostomy kit, oxygen, air and nitrous oxide breathing gas mixer, and epidural anaesthesia kit have been classified under risk class C. It may be noted that the government had earlier this week announced capping of trade margins for five medical devices including pulse oximeter.
Aerosol face mask, aerosol inhalation monitor, airway pressure or oxygen monitor device among others have been classified under risk class B. Devices including anaesthesia catheter luer connector, anaesthesia depth simulator, anaesthesia instrument table and others have been classified under risk class A.
Risk Class A is considered as lower risk, while Class B is low moderate risk and Class C is moderate high risk. The classification is based on the intended use of the device, risk associated with the device and other parameters specified under the Medical Devices Rules, 2017.
Of the devices classified under the new notice, almost 49 are under Risk Class A, and around 45 are under Risk Class B, while the rest are under Class C.
Accessories and components of medical devices imported as a system need not be registered separately. However, this does not debar from risk based classification of the accessories or components of medical devices, it said.
The anaesthetics and catheters of cardio respiratory devices manufacturing is supported by the Department of Pharmaceuticals under production linked incentive (PLI) scheme to boost domestic manufacturing.
The Central Drugs Standard Control Organisation (CDSCO) had earlier this month updated the list of medical device testing laboratories registered with the regulator to 14 across the country. There are more applicants which are under evaluation, said CDSCO.